Brand Names:

Dosage Forms:

Classifications:

Uses of This Medicine:

Hydrocodone and pseudoephedrine combination is used in adults 18 years of age and older to relieve cough and nasal congestion (stuffy nose) caused by the common cold.

Hydrocodone is a narcotic antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve cough. Pseudoephedrine is a decongestant, which decreases nasal congestion by narrowing the blood vessels and reducing blood flow to the nasal passage.

When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing cough and nasal congestion should not let the fear of dependence keep them from using narcotics to relieve their cough. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use of hydrocodone and pseudoephedrine combination is not indicated in children younger than 18 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and pseudoephedrine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy—

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Clorgyline

Dihydroergotamine

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Moclobemide

Naltrexone

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone Acetate

Acetophenazine

Alfentanil

Alprazolam

Amobarbital

Amprenavir

Anileridine

Aprepitant

Atazanavir

Baclofen

Bosentan

Bromazepam

Brotizolam

Buprenorphine

Buspirone

Butabarbital

Butalbital

Butorphanol

Carbamazepine

Carbinoxamine

Carisoprodol

Ceritinib

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Ciprofloxacin

Clarithromycin

Clobazam

Clonazepam

Clorazepate

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Dabrafenib

Dantrolene

Darunavir

Delavirdine

Dexamethasone

Dexmedetomidine

Dezocine

Diacetylmorphine

Diazepam

Difenoxin

Dihydrocodeine

Diltiazem

Diphenhydramine

Diphenoxylate

Dixyrazine

Doxylamine

Efavirenz

Enzalutamide

Erythromycin

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Ethylmorphine

Etravirine

Fentanyl

Fluconazole

Flunitrazepam

Fluphenazine

Flurazepam

Fosamprenavir

Fosaprepitant

Fosphenytoin

Fospropofol

Furazolidone

Guanethidine

Halazepam

Hexobarbital

Hydromorphone

Hydroxyzine

Idelalisib

Imatinib

Indinavir

Iobenguane I 123

Iproniazid

Isocarboxazid

Itraconazole

Ketazolam

Ketobemidone

Ketoconazole

Levorphanol

Linezolid

Lomitapide

Lopinavir

Lorazepam

Lormetazepam

Loxapine

Meclizine

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Meptazinol

Mesoridazine

Metaxalone

Methadone

Methdilazine

Methocarbamol

Methohexital

Methotrimeprazine

Methyldopa

Methylene Blue

Metopimazine

Miconazole

Midazolam

Midodrine

Mifepristone

Mitotane

Moclobemide

Modafinil

Morphine

Morphine Sulfate Liposome

Nafcillin

Nalbuphine

Nefazodone

Nelfinavir

Nevirapine

Nicomorphine

Nitrazepam

Opium

Opium Alkaloids

Orphenadrine

Oxazepam

Oxcarbazepine

Oxycodone

Oxymorphone

Papaveretum

Paregoric

Pentazocine

Pentobarbital

Perampanel

Perazine

Periciazine

Perphenazine

Phenelzine

Phenytoin

Piperaquine

Pipotiazine

Piritramide

Posaconazole

Prazepam

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propiomazine

Propofol

Quazepam

Ramelteon

Rasagiline

Regorafenib

Remifentanil

Rifabutin

Rifampin

Rifapentine

Ritonavir

Saquinavir

Secobarbital

Selegiline

Siltuximab

Sodium Oxybate

St John's Wort

Sufentanil

Suvorexant

Tapentadol

Telaprevir

Telithromycin

Temazepam

Thiethylperazine

Thiopental

Thiopropazate

Thioproperazine

Thioridazine

Ticagrelor

Tilidine

Tipranavir

Tizanidine

Topiramate

Tramadol

Tranylcypromine

Triazolam

Triflupromazine

Trimeprazine

Verapamil

Voriconazole

Zaleplon

Zolpidem

Zopiclone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Escitalopram

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Addison's disease (adrenal gland problem) or

Asthma or

Diabetes or

Drug dependence, especially narcotic abuse or dependence, or history of or

Enlarged prostate (BPH, prostatic hypertrophy) or

Problems with passing urine or

Thyroid disease—Use with caution. May increase risk for more serious side effects.

Heart disease (e.g., coronary artery disease), severe or

Hypertension (high blood pressure), severe or

Narrow angle glaucoma or

Urinary retention—Should not be used in patients with these conditions.

Kidney disease, severe or

Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

Measure the oral liquid correctly using the marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Ask your pharmacist for instructions for measuring the correct dose of this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (solution):

For relief of cough and nasal congestion:

Adults—5 milliliters (mL) every 4 to 6 hours as needed. However, the dose is usually not more than 4 doses (20 mL) in 24 hours.

Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If your symptoms do not improve or if they get worse, call your doctor.

Do not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

Symptoms of an overdose include: extreme dizziness or weakness, shortness of breath, slow heartbeat or breathing, seizures, and cold, clammy skin. In case of an overdose, call your doctor right away.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, fever, high-pitched cry, irritability, shakiness or tremor, vomiting, weight loss, or failure to gain weight.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

confusion

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, slow, or irregular heartbeat

sweating

unusual tiredness or weakness

Incidence not known

Abdominal or stomach cramps or pain

bloating

bulging soft spot on the head of an infant

change in the ability to see colors, especially blue or yellow

convulsions

decrease in the frequency of urination

decrease in urine volume

diarrhea

difficult or painful urination

difficult or troubled breathing

difficulty having a bowel movement (stool)

difficulty in passing urine (dribbling)

drowsiness

frequent urge to urinate

headache

irregular, fast or slow, or shallow breathing

loss of appetite

nervousness

pale or blue lips, fingernails, or skin

pounding in the ears

shakiness in the legs, arms, hands, or feet

shortness of breath

sleeplessness

trembling or shaking of the hands or feet

trouble with sleeping

unable to sleep

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: